Republic Act 4688
Clinical Laboratory Law
Comprised of eight (8) sections only
Approved on June 18, 1966
Section 1
Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from humans or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health
government hospital laboratories doing routine or minimum laboratory examinations
Section 1:
shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories
Section 2
It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually
such laboratory is under the administration, direction and supervision of an authorized physician
Section 2:
No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless
Section 3
The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions
Section 4
Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished
not less than one month but not more than one year
Section 4:
imprisonment
not less than one thousand pesos nor more than five thousand pesos
Section 4:
fine
Section 5: Separability clause
If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof
fifty thousand pesos
Section 6:
The sum of ___, or so must thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury
Section 7: Repealing clause
All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.
Executive Order No. 102, Series of 1999
Redirecting the Functions & Operations of DOH
Administrative Order No. 59, Series of 2001
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines
Administrative Order No. 2007-0027
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
Administrative Order No. 2008-0002
Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities
Administrative Order No. 2008-0007
Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories
Administrative order No. 2021-0037
New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines
Health Facilities and Service Regulatory Bureau (HFSRB)
specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories
formerly BHFS (Bureau of Health Facilities & Services)
Applicant
Definition of Terms:
natural or juridical person who intends to operate a clinical laboratory
CHD
Definition of Terms:
Center for Health Development
Clinical Laboratory
Definition of Terms:
facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases
Critical Values
Definition of Terms:
panic values originally described by Lundberg as "life-threatening" unless something is done promptly and for which some corrective action could be undertaken
EQAP
Definition of Terms:
External Quality Assessment Program; program where participating laboratories are given unknown samples for analysis
Assessment Tool
Definition of Terms:
checklist used by regulatory officers during inspection visits to evaluate compliance of clinical laboratory to minimum standards and technical requirements
AO 2021-0037 Annex B1
Definition of Terms:
ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex B2
Definition of Terms:
EQUIPMENT/INSTRUMENT S/GLASSWARE/SUPPLIES/ REAGENTS PER AREA OF ACTIVITY/SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex C
Definition of Terms:
PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES
AO 2021-0037 Annex D1
Definition of Terms:
PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex D2
Definition of Terms:
CHECKLIST FOR REVIEW OF FLOOR PLANS GENERAL CLINICAL LABORATORY
AO 2021-0037 Annex E
Definition of Terms:
GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORIES
AO 2021-0037 Annex F
Definition of Terms:
APPLICATION FORM FOR CERTIFICATE OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY
Institution
Definition of Terms:
corporate body or establishment organized for an educational, medical, charitable or similar purpose
License
Definition of Terms:
issued by DOH to an individual, agency, partnership or corporation that operates a clinical laboratory upon compliance with the requirements set forth
Licensee
Definition of Terms:
individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance
Mobile Clinical Laboratory
Definition of Terms:
laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location; shall have a base laboratory
Monitoring Examinations
Definition of Terms:
tests done in series on patients as a guide for treatment or follow-up of their condition
NRL (National Reference Laboratory)
Definition of Terms:
laboratory in a government hospital designated by DOH to provide special functions and services for specific disease areas
POL (Physician’s Office Laboratory)
Definition of Terms:
individual doctor's office/ clinic wherein laboratory examinations are performed
POCT (Point of Care Testing)
Definition of Terms:
diagnostic testing at or near the site of patient care rather than in clinical laboratory; includes bedside testing, outpatient and home care
Routine Tests
Definition of Terms:
basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion
Satellite Testing Site
Definition of Terms:
any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory
STAT Tests
Definition of Terms:
done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure.
Regulations, Licensing, and Enforcement Division (RLED)
Definition of Terms:
A division at the Center for Health Development (CHD) responsible for the issuance of Certificate of Need, Permit to Construct, License to Operate/Authority to Operate, and the conduct monitoring of hospital and health facilities
Permit to Construct
Definition of Terms:
a permit issued by DOH to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents; required for hospitals and other health facilities with substantial alteration, expansion, renovation, or for additional services (add-ons) beyond their service capability
Initial Application
Definition of Terms:
refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovation
National External Quality Assessment Scheme (NEQAS)
Definition of Terms:
an EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.
Referral Tests
Definition of Terms:
refers to CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.
National Kidney and Transplant Institute (NKTI)
National Reference Laboratories:
Hematology
Immunohematology
Urinalysis
STD/AIDS Central Cooperative Laboratory (SACCL)
National Reference Laboratories:
Serology
Lung Center of the Philippines (LCP)
National Reference Laboratories:
Clinical Chemistry
East Avenue Medical Center (EAMC)
National Reference Laboratories:
Drug Testing
Water Microbiology
Micronutrient Assay
Research Institute of Tropical Medicine (RITM)
National Reference Laboratories:
Microbiology
Parasitology
Government
Classification of Laboratories: By Ownership
operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board or agency thereof
Private
Classification of Laboratories: By Ownership
privately owned, established and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization
Clinical Pathology
Classification of Laboratories: By Function
deals with the chemical and cellular analyses of blood and other body fluids
Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring
Anatomical Pathology
Classification of Laboratories: By Function
provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues
Surgical Pathology, lmmunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology
Molecular Pathology
Classification of Laboratories: By Function
deals with the analysis of certain genes, proteins and other molecules in samples from organs, tissues or bodily fluids in order to diagnose disease
Institution-based
Classification of Laboratories: By Institutional Character
a laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center
A laboratory that is located within the premises and operates as part of a DOH licensed health facility.
Free-standing/Non-institutional based
Classification of Laboratories: By Institutional Character
a laboratory that does not form part of any other institution
A laboratory that operates independently and is not attached to any DOH licensed health facility.
Primary
(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL
Routine Hematology
Complete Blood Count
Hemoglobin
Hematocrit
WBC Count
WBC Differential Count
Qualitative Platelet Determination
Routine Urinalysis
Routine Fecalysis
Blood Typing (hospital based)
Clinical Microscopy
Clinical Chemistry
Serology/Immunology
Microbiology
AO 2021-0037:
Primary Laboratory additions
Secondary
(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL
Routine Clinical Chemistry
Glucose
Blood Urea Nitrogen
Uric Acid
Creatinine
Total Cholesterol
Quantitative Platelet Determination
Cross Matching (hospital based)
Gram Staining (hospital based)
KOH (hospital based)
Tertiary
(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL
Special Chemistry
Special Hematology, including coagulation procedures
Immunology
Microbiology
Culture & Sensitivity
Aerobic & Anaerobic (for hospital based)
Aerobic or Anaerobic (for non-hospital based)
Limited Service Capability
Classification of Laboratories: By Service Capability: General CL
Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics
Clinical Laboratory for Anatomic Pathology
Classification of Laboratories: By Service Capability: General CL
provides services for any of the following, but not limited to: cytology and histopathology
Clinical Laboratory for Molecular Pathology
Classification of Laboratories: By Service Capability: General CL
provides services for genetics, immuno/hematopathology and infectious disease. COVID-19 testing laboratories shall be covered by another order.
Clinical laboratories exclusive for research and teaching purposes
General Guidelines:
shall be exempted from the licensing requirement but shall be required to register
Assisted Reproduction Technology
Molecular & Cellular Technology
Molecular Biology
Molecular Pathology
Forensic Pathology
Anatomic Pathology
General Guidelines: Special Laboratories
license of clinical laboratory of the hospital
General Guidelines:
NRL shall be covered by ___
required
General Guidelines:
POL ___ to secure a LTO
management of clinical laboratory
General Guidelines:
POCT (in hospital) required under ___
Pathologist
Specific Guidelines: Human Resources
Head of Laboratory
shall have administrative and technical supervision of the activities in the laboratory
workload and services being provided
Specific Guidelines: Human Resources
number of staff shall depend on ___
Rotation 24-hour duty
Specific Guidelines: Human Resources
Microscopy, Hematology, Clinical chemistry
minimum of 8, maximum of 12
Specific Guidelines: Human Resources
Working hours
50 tests
Specific Guidelines: Human Resources
Manual testing: 8 hours
75 tests
Specific Guidelines: Human Resources
Manual testing: 12 hours
100 tests
Specific Guidelines: Human Resources
Automated testing: 8 hours
150 tests
Specific Guidelines: Human Resources
Automated testing: 12 hours
10 sq m
Specific Guidelines: Physical Facilities: Minimum Technical Working Area
Primary
20 sq m
Specific Guidelines: Physical Facilities: Minimum Technical Working Area
Secondary
60 sq m
Specific Guidelines: Physical Facilities: Minimum Technical Working Area
Tertiary
Satisfactory performance rating
Specific Guidelines: Physical Facilities: Quality Control Program
criteria for renewal of license
Refusal to participate in EQAS-NRL
Specific Guidelines: Physical Facilities: Quality Control Program
basis for suspension/revocation of license
Reporting
Specific Guidelines: Physical Facilities
Bear the name and signature of Pathologist & RMT
No report orally or in writing without directive from pathologist or associate except in emergency cases
Recording
Specific Guidelines: Physical Facilities
All requests and reports of all specimens submitted and examined
Kept in file for at least 1 year
kept permanently
Specific Guidelines: Physical Facilities: Recording
Anatomic and forensic pathology reports
One-Stop-Shop Licensure System
Renewal of LTO:
Hospitals
first day of October to last day of November
Renewal of LTO:
Non-hospitals: discount on renewal fee if application completed during this period
5 working days
Renewal of LTO:
processed not later than ___ after expiration date of LTO
automatically cancelled without notice
Renewal of LTO:
LTO ___ when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license
accessibility of premises and facilities for inspection
Inspection:
Licensee shall ensure ___ of CHD Director or authorized representative(s) at any reasonable time
availability of all pertinent records for checking/review
Inspection:
Licensee shall ensure ___ of CHD Director or his authorized representative(s)
Refusal
Violations:
___ on any clinical lab to participate in EQAP
Issuance of a report, orally or in writing
Violations:
___ (in whole or part thereof) which is not in accordance with documented procedures
perform technical procedures
Violations:
Permitting unauthorized persons to ___
Deviations
Violations:
___ from standard test procedure
unlicensed laboratory
Violations:
Lending or using the name of licensed laboratory or head or RMT to an ___
secure LTO
Violations:
Unauthorized use of the name and signature of Pathologist and RMT to ___